Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of BIA 2-093

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined

Detailed Description

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Portugal
  • S. Mamede do Coronado, Portugal, 4045-457
    • Bial - Portela & Cª, S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pre-menopausal female;
• Able and willing to give written informed consent;
• Aged 18 to 40 years, inclusive;
• Not pregnant or breast-feeding;
• Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
• Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;
• Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
• Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
• Negative test for drugs of abuse at screening;
• Non-smoker or smokes less than 10 cigarettes or equivalent per day;
• Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
• Negative pregnancy test at screening and admission to the first period.

Exclusion Criteria:

• Had any contra-indication to the use of oral contraceptives;
• Had experienced notable adverse events while on any oral contraceptive;
• Had a history of alcoholism or drug abuse;
• Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
• Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
• Had a significant infection or inflammatory process at the time of screening or admission to the first period;
• Had a relevant surgical history;
• Had a relevant family history;
• Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
• Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
• Consumed more than 14 units of alcohol a week;
• Had participated in any clinical trial within 3 months prior to screening;
• Had previously received BIA 2-093;
• Had donated or received any blood or blood products within 2 months prior to screening;
• Was unlikely to co-operate with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment sequence A; oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive	Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined
Other: Treatment sequence B; oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days	Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Plasma BIA 2-194 Concentration	Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.	Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)	pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Tmax	Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)	pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
AUC0-t	AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)	pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: November 28, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Eslicarbazepine acetate; Contraceptives, Oral, Combined
• Other Study ID Numbers: BIA-2093-114